Tirzepatide in MetALD
Eligible age
21–100 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
Background: People with alcohol use disorder (AUD) often develop metabolic alcohol-associated liver disease (MetALD). MetALD is a term for the heart, liver, obesity, and other issues that can accompany AUD. MetALD can be fatal. An approved weight management drug (Tirzepatide) may be able to help people with AUD and MetALD control their alcohol intake. Objective: To test Tirzepatide in people with AUD and MetALD. Eligibility: People aged 21 years and older with AUD and MetALD. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have a test of their heart function. They will have a Fibroscan: This test uses ultrasound to measure how stiff the liver is. They will answer questions about their alcohol drinking, eating habits, and mental health. Participants may opt to have imaging scans of their brain and liver. These tests will be repeated in a baseline visit. This visit will take up to 6 hours. Tirzepatide is injected under the skin once a week for 12 weeks. Participants will visit the clinic to receive each injection. Some participants will get a placebo. A placebo is given just like a Tirzepatide injection but contains no medicine. The physical exam and other tests will be repeated during clinic visits. The Fibroscan will be repeated every 2 weeks during the study. Each weekly visit will take up to 3 hours. All tests will be repeated on the last visit. These tests will include the imaging scans and Fibroscan. Participants will learn about treatment options for AUD; they will be given recommendations on ways to reduce alcohol intake. This visit will take up to 6 hours.
Sponsor: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
You may not qualify if…
- ✕ An individual who meets any of the following criteria will be excluded from participation in this study:
- ✕ 1. Treatment seeking for alcohol use disorder
- ✕ 2. History of a serious hypersensitivity reaction to GLP-1RA/GIPRA
- ✕ 3. Current/past use of GLP-1RA/GIPRA within the last 3 months
- ✕ 4. Clinically significant and/or unstable cardiovascular disease over the past 12 months
- ✕ 5. History of diabetes mellitus or blood hemoglobin A1c (HbA1c) \>= 6.5 % at screening
- ✕ 6. Any underlying clinically significant and/or unstable acute or chronic liver disease unrelated to alcohol use at screening, history of cirrhosis, esophageal varices
- ✕ 7. Subjects with platelets count of less than 110,000/ mm\^3
Where it's recruiting
Bethesda
Source: ClinicalTrials.gov · NCT07046819 · last updated 2026-07-22